Project Management Featured Articles
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Thinking Outside The Box: A New Approach To Managing Adaptive Trials
12/1/2014
A large contract research organization, with funding from the National Institutes of Health, needed to find a simpler way to handle changes in clinical-trial protocols once its clinical trials were under way. Although the organization is a leading research institute that routinely conducts numerous clinical trials in the United States and around the world, its researchers and trial site personnel were manually performing many tasks, such as using paper forms and spreadsheets in the clinics to schedule and record visits and to track each trial participant’s progress. These manual approaches severely limited the number of studies and participants the organization could manage at any given time.
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The Micro-Innovators Part 2: Small Enterprises Make Outsized Contributions With Novel Drugs
1/5/2014
Many companies may deserve coverage under the definition of “micro-innovators” as companies developing unique therapeutics they have themselves discovered. But here I have chosen three companies that have chosen the toughest possible route in the life science industry: taking an innovative path from the earliest stages of research through the entire course of product development.
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Your CRO Just Acquired Another CRO – Now What?
7/27/2013
A year ago, Wendel Barr, CEO of CRO Synteract, was frustrated. His company was profitable, he had talented personnel, Synteract was managing a wide variety of projects, and his clients were satisfied with their level of service. Despite this success, his potential to grow the business was constrained. Synteract was a U.S.-based firm with limited presence overseas. As a result, his company often found itself forced to leave money on the table, especially as its customers moved to larger, Phase 3 trials. “It became clear to us that in order to provide the range of services our customers required, we had to have more offices in Europe, beyond our office in Prague,” he says. “If you want to be a full service provider from Phase 1 to Phase 4, you have to be global.”
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Global Call Centers For Life Sciences Organizations
5/7/2013
When we think of call centers, images of the past tend to come to mind. We are reminded of the switchboard ladies in Mad Men, or outsourced client service centers where operators may not have the right linguistic or industry-specific knowledge to fully assist the customer. By Michael Smyth, General Manager, TransPerfect Life Sciences Solutions
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Effective Project Teams: The Importance Of Cooperative Relationships
4/17/2013
When you take a close look at top performing teams you will find highly cooperative relationships. These “Super” teams can routinely meet the needs of its members and the organization in an efficient and sustainable fashion. By Kelly J. Hill, MS, CRDSA, Director, Project & Account Management
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Outsourcing Insights From The President Of A Virtual Drug Discovery Company
4/16/2013
Carolyn Green, is the President and Director for Atreaon, Inc., a privately held biopharmaceutical company developing a novel engineered protein called Atsttrin, for the treatment of inflammatory diseases such as rheumatoid arthritis. Having recently completed a $20 million Series A financing to support the pre-clinical development of Atsttrin, Green took time out from her busy schedule to share some of her thoughts and insights regarding the outsourcing of clinical research.
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Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20%
3/26/2013
Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.
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Perception And Reality At CROs
3/4/2013
Like everything else, outsourcing has its pluses and minuses. Bruce Rehlaender of PharmaDirections discusses what you need to know about the CRO you’re about to sign to a contract.
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Singapore Reduces Risks To Life Sciences Entering The Asian Market
12/28/2012
There are many risks involved with opening pharmaceutical manufacturing operations in Asia, but Signapore has become ideal for the Life Sciences industry.
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Executive Insights From A China-Based Biotech On Selecting A CRO
5/21/2012
Coreen Oei, Ph.D. is the SVP of clinical operations and project management at BeiGene. Oei oversees the execution of clinical trials and the development of budgets and project timelines for BeiGene’s clinical portfolio. Prior to joining BeiGene, she spent 10 years at GlaxoSmithKline where her most recent role was VP, Scientific and Clinical Operations in the Virtual Proof of Concept Unit. Oei recently took time out to answer some questions posed to her by Life Science Leader magazine on her approach to selecting a contract research organization (CRO) from the perspective of a China-based biotech. By Rob Wright, Chief Editor, Life Science Leader magazine